Status:
COMPLETED
Percutaneous Radiofrequency Ablation of Parietal Endometriosis (PRFA)
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Endometriosis
Eligibility:
FEMALE
25+ years
Phase:
NA
Brief Summary
Parietal endometriosis is the implantation of endometrial tissue in abdominal structures more superficial than the peritoneum. It is a rare form of the disease (incidence estimated between 0.04 and 12...
Eligibility Criteria
Inclusion
- Patient over 25 years of age;
- Presenting between 1 and 3 lesions of parietal endometriosis, all accessible to radiofrequency treatment, with a major axis less than 10cm;
- Symptomatic (chronic and/or catamenial pain);
- Histological diagnosis of endometriosis;
- In failure of medical treatment;
- Nodule visible on ultrasound;
- Affiliated with or beneficiary of a social security or similar scheme.
- Having signed an informed consent for participation in the study
Exclusion
- Presence of a parietal endometriosis lesion with superficial skin involvement (dermis);
- Presence of other symptomatic extra-parietal endometriosis lesions for which surgical treatment is planned;
- Uncontrolled diabetes, i.e. HbA1c \>7% despite well-treated and well-controlled treatment;
- Contraindication to the use of radiofrequency: implanted electronic device, such as a pacemaker or self-synchronizing defibrillator; weakened immune system; coagulation disorder;
- Contraindication to the use of Sonovue
- Contraindication to the use of gadolinium
- Severe renal failure (glomerular filtration rate less than 30 ml / min / 1.73m²)
- Pregnant patient or with a desire to become pregnant within 6 months after treatment;
- Patient who is not fluent in the English language;
- Patient over the age of majority protected by law, under curatorship or guardianship;
- Person deprived of liberty by a judicial or administrative decision, person subject to psychiatric care and people admitted to a health or social establishment for purposes other than that of research.
- Patient participating in other interventional research that may interfere with the present research (at the discretion of the investigator);
- Patient who has participated in other research that includes an ongoing opt out period.
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04333017
Start Date
June 12 2020
End Date
January 31 2023
Last Update
August 8 2025
Active Locations (1)
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1
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, France, 69002